MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 4.1MMD, 8MML; DENTAL IMPLANT

Catalog Number	TSX41B8
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).
Event or Problem Description
It was reported a lack of primary stability observed during the clinical procedure at tooth site 15 with migration into sinus.Implant was removed.Doctor will wait for healing to place a new implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) tsx41b8, (tsx implant, 4.1mmd, 8mml) for evaluation.Visual evaluation was performed, the implant had signs of use with debris on its external threads.There was no damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.Device history record (dhr) review was completed for the subject lot number 2120017098.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120017098 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: lack of primary stability and dental: medical: perforated sinus based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error and patient factors.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable with all the available information provided.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: TSX IMPLANT, 4.1MMD, 8MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22708231
• Report Number: 0001038806-2025-01853
• Device Sequence Number: 15792139
• Product Code: DZE
• UDI-Device Identifier: 00844868045144
• UDI-Public: (01)00844868045144(17)290731(10)2120017098
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: TSX41B8
• Device Lot Number: 2120017098
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic